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Low Glycemic Index Diet in Patients With Type 1 Diabetes (LGID1)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Low GI food
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Glycemic Index Diet, HbA1c, Lipids

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type I diabetes, durability >5 years
  • Age 20-65 years
  • Normal weight (BMI 19-26 kg/m2)
  • Diabetic treatment with mealtime and bedtime insulin.
  • HbA1c ≤10 %
  • Informed consent to participate in the study.

Exclusion Criteria:

  • Diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
  • A known food intolerance of gluten, leguminous plants, nuts or almonds.
  • Pregnancy or breast-feeding.
  • Concurrent participation in another research study with metabolic effects.
  • Previously regular follow-up with a dietician at SDC during the last year.
  • Adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.
  • Non acceptance of the study diet or food products that are recommended in the study.
  • Disability to read and understand the Danish language.
  • Unable to receive and/or store the test products.
  • Place of residence >1 hr drive from SDC.

Sites / Locations

  • Steno Diabetes Center

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

LDL-cholesterol

Full Information

First Posted
August 17, 2010
Last Updated
September 2, 2010
Sponsor
Steno Diabetes Center Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01184703
Brief Title
Low Glycemic Index Diet in Patients With Type 1 Diabetes
Acronym
LGID1
Official Title
Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Steno Diabetes Center Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes.
Detailed Description
The glycemic index (GI) was introduced by Jenkins and co-workers in the early 1980s, and is a concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. A meta-analysis of randomised controlled trials of the effect of low GI diets in the management of diabetes showed a beneficial effect (i.e., a reduction in HbA1c) of low GI versus high GI foods. However, several critical points concerning the GI concept remain, for instance, how to apply it in practical every day life, how to calculate GI in mixed meals, how to find relevant low GI foods, how to ensure compliance to a low GI diet. The most important issue, however, is the fact that studies on the long-term effects of a low GI diet in type 1 diabetes are lacking. In this study, the critical issue of finding palatable low GI foods will be solved in close collaboration with the food industry. This may lead to the development of new commercial products with low GI, which is necessary if low GI diets are to be advocated for diabetics in the future. Comparison(s): A low glycemic index diet, compared to a medium/normal glycemic index diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Type 1, Glycemic Index Diet, HbA1c, Lipids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Low GI food
Intervention Description
Comparison of carbohydrates in diabetic patients
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
3 months
Secondary Outcome Measure Information:
Title
LDL-cholesterol
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type I diabetes, durability >5 years Age 20-65 years Normal weight (BMI 19-26 kg/m2) Diabetic treatment with mealtime and bedtime insulin. HbA1c ≤10 % Informed consent to participate in the study. Exclusion Criteria: Diabetic complications; neuropathy, foot ulcers and/or gastroparesis. A known food intolerance of gluten, leguminous plants, nuts or almonds. Pregnancy or breast-feeding. Concurrent participation in another research study with metabolic effects. Previously regular follow-up with a dietician at SDC during the last year. Adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects. Non acceptance of the study diet or food products that are recommended in the study. Disability to read and understand the Danish language. Unable to receive and/or store the test products. Place of residence >1 hr drive from SDC.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Bensow Bacos, Ch Diet
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
DK-2820
Country
Denmark

12. IPD Sharing Statement

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Low Glycemic Index Diet in Patients With Type 1 Diabetes

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